{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Rochester",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA018261"
        ],
        "brand_name": [
          "PITOCIN"
        ],
        "generic_name": [
          "OXYTOCIN"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "42023-116"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "OXYTOCIN"
        ],
        "rxcui": [
          "207315",
          "238013",
          "1791721",
          "1791723"
        ],
        "spl_id": [
          "04b9ce17-ec8a-456b-843a-a5e105dc39f7"
        ],
        "spl_set_id": [
          "969d5b35-0add-4c23-9605-6a5b6ab65c95"
        ],
        "package_ndc": [
          "42023-116-25",
          "42023-116-01",
          "42023-116-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000009705",
          "N0000175828",
          "M0015703"
        ],
        "pharm_class_pe": [
          "Increased Uterine Smooth Muscle Contraction or Tone [PE]"
        ],
        "pharm_class_epc": [
          "Oxytocic [EPC]"
        ],
        "pharm_class_cs": [
          "Oxytocin [CS]"
        ],
        "unii": [
          "1JQS135EYN"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62013",
      "recalling_firm": "JHP Pharmaceuticals, LLC",
      "address_1": "870 Parkdale Rd",
      "address_2": "",
      "postal_code": "48307-1740",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1420-2012",
      "product_description": "Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02",
      "product_quantity": "26100 vials",
      "reason_for_recall": "Labeling: Label Mix-up: Pitocin storage conditions should be labeled, \"Store between 20¿ to 25¿C (68¿ to 77¿F)\". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, \"Store between 20¿ to 25¿C (28¿ to 77¿F)\".",
      "recall_initiation_date": "20120605",
      "center_classification_date": "20120716",
      "termination_date": "20121105",
      "report_date": "20120725",
      "code_info": "Lot  231423, 255867",
      "more_code_info": ""
    }
  ]
}